Tela Bio, Aroa Biosurgery win FDA nod for large-size OviTex bioscaffolds

Aroa Biosurgery, Tela Bio

Tela Bio and its partner Aroa Biosurgery said yesterday that it won FDA 510(k) clearance for large-size OviTex reinforced bioscaffolds intended for soft tissue repair.

The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Malvern, Penn.-based Tela Bio said.

With the clearance, the companies said that they will now offer the OviTex RBS devices in the US in sizes up to 20×40 cm, a 150% surface area increase over its currently available offerings.

“We are pleased to launch larger OviTex RBSs as we continue our mission to provide valuable solutions for a full range of hernia repairs and abdominal wall reconstructions, including the most complex cases. Traditionally, large abdominal wall hernias can present a technical challenge for some surgeons. Our devices are now positioned to ensure that patients who are most at need have access to the most advanced technology to assist with their hernia repair,” Tela Bio prez & CEO Antony Koblish said in a prepared statement.

“The ability to cover a larger surface area could have many potential benefits for patients and surgeons in terms of securing the most complex hernia repairs properly and reducing the risk of recurrence. As a joint developer and the manufacturer of the Ovitex technology, it is encouraging to see growing demand and the continued expansion of our product portfolio. We provide a robust and comprehensive suite of accessible and affordable options that address the current shortcomings in surgical hernia repair solutions,” Aroa Biosurgery CEO Brian Ward said in a press release.

Last May, Tela Bio and Aroa Biosurgery said they won CE Mark approval in the European Union for the OviTex RBS, which Tela Bio commercially launched in the region.

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PolarityTE registers bone repair product with FDA

PolarityTE updated logoPolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA.

The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells.

Get the full story at our sister site, Drug Delivery Business News.

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Kuros raises $16m for bone-growth protein

Kuros BiosciencesKuros Biosciences (SIX:KURN) said this week that it raised more than $16 million for clinical trial of its bone-growth protein as it expands the commercial footprint for its MagnetOs bone graft substitute.

Proceeds from the CHF 16.1 million round are earmarked for a Phase II trial of the Fibrin-PTH protein in spinal fusion procedures and for the commercialization of MagnetOs, which won 510(k) clearance from the FDA in August 2017 and CE Mark approval in the European Union in May. Kuros won CE Mark approval in the European for its Neuroseal dural sealant in June 2017.

The Zurich-based company said it plans to launch the study during the second quarter of 2019, with interim data due by the second half of 2020.

“We have made excellent progress on our new course in 2018 and have a strong team in place to take the company forward. The recent capital raise adds to those solid foundations and allows us to build on that success. The first sales of MagnetOs are a realization of the hard work and dedication the Kuros team has put in and we are now focusing on the commercial roll-out, which is proceeding well. On top of that, we are pushing on with the exciting Fibrin-PTH program. Largely de-risked in successful trauma trials, it targets an important medical need in spinal fusion, which represents a significant commercial opportunity,” CEO Joost de Bruijn said in prepared remarks.

$1 = CHF 0.991442

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MiMedx escapes Osiris trade theft suit

MiMedx, Osiris

MiMedx (NSDQ:MDXG) enjoyed a rare spot of good news when a federal judge in Maryland this week dismissed a trade theft and breach-of-contract lawsuit brought by Osiris Therapeutics over MiMedx’s  Stability Biologics acquisition.

Columbia, Md.-based Osiris said it inked a distribution deal back in 2013 to have Stability sell a pair of its products through the end of 2015. But after MiMedx paid $10 million for Stability in January 2016, it allegedly gained access to Osiris trade secrets and fostered a series of events leading to $6.8 million in losses for Osiris.

(In an about-face in August 2017, MiMedx agreed to sell Stability back to its original owners; that sale closed last October.)

The lawsuit, filed in April in the U.S. District Court for Maryland, alleged that MiMedx held on to Osiris inventory worth $2.2 million, plus $1.3 million in pre-paid commissions, and directed Stability not to pay another $2.9 million allegedly owed under a payment plan; Osiris allegedly incurred another $321,000 in legal fees from its attempt to recoup its losses in arbitration.

MiMedx filed a motion to dismiss for lack of jurisdiction. In a Dec. 11 ruling, Judge Catherine Blake ruled that Osiris failed to prove either general or specific jurisdiction in the case.

“None of MiMedx’s alleged contacts with Maryland – which, even by Osiris’s characterization are limited to the acquisition of a subsidiary that owed debts to a Maryland corporation and the operation of a single tissue bank in-state – suffice to give rise to general jurisdiction,” Blake wrote.

“Osiris improperly merges Stability’s contacts with MiMedx’s contacts,” she wrote. “MiMedx’s only contact with Maryland is its distribution of amniotic tissue through a Maryland tissue bank. … [T]his contact is insufficient to support specific jurisdiction in Maryland. “

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Shareholders approve Avista, Organogensis tie up

Avista Capital Partners, Organogensis

Private equity firm Avista Healthcare Public Acquisition Corp. yesterday approved its merger with regenerative medicine company Organogenesis.

The merger won approval yesterday at separate special meetings of shareholders for both companies, Canton, Mass.-based Organogenesis said.

As part of the deal, Avista invested a total of $92 million in the combined company, Organogenesis said. Avista also said it plans to deregister in the Cayman Islands and incorporate in Delaware, according to an SEC filing.

The company is slated to be run by Organogenesis’ existing management team, led by CEO Gary Gillheeney Sr., the company said in a press release.

“We are delighted to have completed this transaction and look forward to capitalizing on Tom Dean and Avista’s strategic expertise as Organogenesis uses the capital from this investment to execute on its compelling growth objectives and continues to deliver its customers a versatile product portfolio to substantially improve the lives of their patients,” Gillheeney said in a press release.

Organogensis is a regenerative medicine company producing devices for wound care, surgical and the sports medicine markets, Avista said. The company has over 600 employees globally.

“We are pleased to have closed this transaction with Organogenesis and look forward to a very successful partnership. Organogenesis is an ideal partner for Avista, given its leading position in the rapidly accelerating regenerative medicine sector, numerous growth opportunities and demonstrated ability to execute on product development and commercialization capabilities. Collectively, we will work to create tremendous value for Organogenesis’ patients, investors, employees and key stakeholders,” Avista co-CEO & managing partner Thompson Dean said in a press release.

The companies originally announced the acquisition in August.

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MiMedx accounting firm quits

MiMedxThe troubles at MiMedx (NSDQ:MDXG) continued last week with the resignation of the accounting firm tapped to audit its books in the wake of a financial scandal.

Marietta, Ga.-based MiMedx last July ousted ex-CEO Parker Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June.

At the time, MiMedx said it would restate all of its earnings reports going back to 2012 and was cooperating with U.S. Securities & Exchange Commission and Justice Dept. investigations into the matter.

The company later said that all four executives’ departures were for cause, triggering the forfeit of all equity and incentive awards for the executives and Petit’s resignation from the board. Petit and Taylor denied the allegations in a statement from their lawyer.

Last week MiMedx, which makes regenerative and therapeutic biologics using human placental tissue allografts, said the company hired by its board’s audit committee resigned Dec. 4 after determining that it can’t rely on the company’s internal financial controls or the representations from the former executives and their interim replacements.

“EY advised the company that the internal controls necessary for the company to develop reliable financial statements do not exist,” MiMedx said in a Dec. 7 regulatory filing. “Although EY could accept representations from the current interim CEO and interim CFO based on their knowledge, EY advised the company that EY is unable to rely on representations from them because, as of the date of the resignation, the current interim CEO and interim CFO, in turn, would have needed to rely on representations from certain legacy management personnel still in positions that could affect what is reflected in the company’s books and records.”

The accounting firm said it would need to “significantly expand” the scope of its audit, “due to material allegations of inappropriate financial reporting, material allegations of noncompliance with laws and regulations, the findings to date from the independent investigation conducted by the Audit Committee into these allegations, and the lack of internal controls necessary for the company to develop reliable financial statements,” MiMedx said in the filing.

“EY advised the company that information has come to EY’s attention that EY has concluded materially impacts the reliability of previously issued financial statements, and the issues raised by this information have not been resolved to EY’s satisfaction prior to its resignation,” MiMedx said.

MDXG shares closed down -4.2% at $1.15 apiece Dec. 7.

Last week the company said it’s planning to lay off 24% of its workforce in a restructuring effort.

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FDA warns Globus subsidiary HBT over ViaCell production facility issues

Globus Medical

The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April.

The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective actions the company said it was taking in response to the earlier noted issues.

In its in inspection, FDA investigators noted failures to document and investigate deviations in its production of the ViaCell product as well as trends of deviations away from the agency’s core current good tissue practice requirements.

“For example, since the start of ViaCell processing in October 2016 through August 2017, you have had monthly sterility failure rates of [redacted] during seven of those months, with one month having a sterility failure rate of [redacted]. Your firm failed to conduct an investigation of all these sterility failures to determine the cause. You also failed to investigate additional sterility failures that occurred from October 2017 through February 2018. By neglecting to identify the cause of the sterility failures, you also failed to take appropriate corrective action(s) to prevent recurrence of the failures,” the FDA wrote in its letter.

The agency also noted a failure to “validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests,” according go the FDA notice. The example provided again related to the facility’s ViaCell manufacturing process.

The federal watchdog said that it has received two responses from the company so far this year, but outlined some “comments and concerns” in relation to their corrective actions.

The FDA said that it received a response in May outlining corrective actions, but voiced concerns that the actions mostly focus on sterility testing which it said were not reliable, and did not address validation issues with the ViaCell manufacturing process. The agency also noted that while the company reported a decrease in sterility failure rate, it did not discuss plans to “determine the cause of the sterility failures” or why the rate of failures was so high.

The federal watchdog also posted a response to a letter received in September with concerns over the company’s corrective steps.

In its response, Globus’ HBT subsidiary said that it launched additional validation activities covering ViaCell production in May, but the FDA stated that its concerns about the firm’s validation of the ViaCell production process remain.

The agency noted a number of issues it has with the company’s corrective process, including another noted reliance on sterility testing and concerns over possible contamination during processing.

“A disinfection or sterilization process must be validated based on the capability of that process to reduce or eliminate an expected level and mix of microorganisms on the particular product that will be put through the process. Thus, you should carefully consider the capability of your microbiological testing, disinfection, and sterilization processes when you evaluate pre-processing cultures to determine whether or not the HCT/Ps should be processed,” the FDA wrote in its notice.

The FDA also knocked the company on not excluding or discarding samples from donors positive for Clostridium, Streptococcus pyogenes or “any other microorganism that you have determined to be difficult to eliminate, unless you have a terminal sterilization process validated to a sterility assurance level of 10-6.”

In its last point, the agency referenced a lack of positive results from all environmental and personnel monitoring sample testing, saying that having producing no positives is “highly unusual, especially when your sterility failure rates were so high.”

“We strongly suggest you review your environmental monitoring program to ensure that it is capable of detecting microorganisms in your environment and on your personnel,” the federal watchdog wrote.

The FDA gave the company 15 working days to respond to the issues.

Last month, Globus Medical posted third quarter earnings that handily topped expectations from analysts on Wall Street.

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RenovaCare chairman ponies up nearly $16m for wound-healing stem cell SkinGun

RenovaCare-logoRenovaCare (Scottsdale, Ariz.) has announced an equity financing for $15.5 million from Kalen Capital Corporation, the family office of Harmel Rayat, who is the majority shareholder and chairman of RenovaCare. The equity financing increases his family office’s total equity investment in RenovaCare to over $20 million.

“Our long-term investment in RenovaCare speaks to our conviction that patients worldwide urgently need and deserve our regenerative SkinGun therapy, which sprays a patient’s own stem cells for rapid self-healing,” Rayat said in a press release. “I’m more confident than ever in our mission to replace painful and costly skin grafting surgeries with an ultra-gentle healing mist of one’s own skin cells. I believe we are in the right place, at the right time and with the right technology.”

The investment round allows the company to move forward in the regulatory approval process and clinical trial program. Rayat’s previous investment rounds allowed for pre-clinical development, product engineering and intellectual property filings.

Get the full story on our sister site, Medical Design & Outsourcing.

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Avita launches pediatric burn trial

Avita Medical

Avita Medical (ASX:AVH) said today that it launched a new trial of its Recell autologous cell harvesting device exploring its use treating pediatric patients.

The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company said.

In the newly launched trial, investigators will compare use of the Recell device to the standard of care for approximately 90 patients under 18 years of age. Patients in the trial will be randomized to be treated with either the Recell system and Biobrane dressing, the dressing alone or the standard of care, silver impregnated silicone lined dressing.

The trial’s primary endpoint will be days to re-epithelization of burn injuries, while secondary endpoints will include pain, patient satisfaction and scarring, according to a press release.

Last month, Avita Medical said that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter.

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U Penn trial regrows dental pulp from baby tooth stem cells

University of Pennsylvania Dental Medicine School

Data from recent clinical trial out of the University of Pennsylvania suggest that the use of stem cells from a patient’s baby teeth could be used to help regrow dental pulp tissue.

Results from the trial, which was conducted in China, were published in the journal Science Translational Medicine.

In the trial, 40 children were selected who had injured a permanent incisor but still had baby teeth, with 30 assigned to the experimental treatment and 10 to the controlled treatment with the standard of care, apexification.

The stem cells, officially known as human deciduous pulp stem cells (hDPSC), are extracted from healthy baby teeth and allowed to reproduce in a lab culture. The resulting cells from the culture are then implanted into an injured tooth, according to a press release.

Patients treated with the hDPSC showed more signs of healthy root development, thicker dentin and increased blood flow. After one year, some patients who had received the hDPSCs had regained sensation in the tooth, while none of the traditionally treated patients had.

Trial researchers also said they found no safety concerns related to immune-system components.

Investigators are now beginning to test the use of cells donated from another person to regenerate dental tissues in adults, and are hopeful they will secure FDA approval to conduct a trial using hDPSCs in the US.

“The results are very exciting. To see something we discovered take a step forward to potentially become a routine therapy is gratifying,” clinical trial lead Songtao Shi of U Penn’s Dental Medicine school said in a press release.

Researchers are hopeful that future use of hDPSCs could include treatment for systemic disease, including lupus.

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